MASS-FIX (MALDI-TOF MS)

A groundbreaking approach to monoclonal protein identification

For patients at risk of plasma cell disorders, early identification is critical to ensure better outcomes. Coined as MASS-FIX, our innovative approach uses matrix-assisted laser desorption/ionization-time of flight mass spectrometry (MALDI-TOF MS), and marks the first major breakthrough in multiple myeloma screening since gel electrophoresis was developed in 1967. 

By weighing M-proteins, we overcome electrophoresis’s limitations in detection and provide the most accurate understanding of a patient’s M-proteins. This novel MASS-FIX testing also helps health care providers understand their patients’ risk of progression to multiple myeloma, (AL) amyloidosis or other diseases.  This level of insight is not possible with traditional testing methods. 

The impact of MASS-FIX extends beyond the hematologic systems into renal and neurologic spheres. As more is learned about the molecular, cytogenic, and protein variations of M-protein disorders, clinicians have discovered additional disease associations. Learn more here.

Multiple Myeloma and MASS-FIX Testing Updates

Watch this video to learn more about updates on multiple myeloma and MASS-FIX: Hot topics, challenges, and solutions for the clinical lab and patient care.

Now included in International Myeloma Working Group recommendations

  • MASS-FIX is now included in International Myeloma Working Group recommendations as an accepted method for screening of M-proteins.
  • MASS-FIX is included in International Myeloma Working Group recommendations as an accepted method for monitoring of M-protein-based diseases such as MGUS and multiple myeloma.

Superior testing for optimal patient care

The new MASS-FIX testing method provides: 

  • Best-in-class screening for multiple myeloma and early identification of myeloma relapse
  • Verifying if a patient’s IgG kappa mass is caused by monoclonal therapeutics or residual disease

 

  • Convenient, clinically relevant information, and industry-leading turnaround times for results 

Screening and diagnosis

DMOGA | Monoclonal Gammopathy, Diagnostic, Serum

Analytic time: 2 days  

  • Assessing the risk of progression from MGUS to multiple myeloma 

PEISO | Protein Electrophoresis and Isotype, Serum

Analytic time: 2 days  

  • Diagnosis of monoclonal gammopathies, when used in conjunction with serum free light-chain studies performed at client site 

SPEP | Electrophoresis, Protein, Serum

Analytic time: 2 - 5 days  

  • Diagnoses monoclonal gammopathies when used in conjunction with MALDI-TOF MS and free light chain analysis.

After diagnosis or amyloidosis suspicion

SMPU | Monoclonal Protein Screen, 24 Hour, Urine

Analytic time: 4–6 days

  • MASS-FIX urine testing, with greater sensitivity than serum for free light chains, can help detect the presence of monoclonal protein in urine that may not have been detected in other serum testing for monoclonal protein or for patients with a high suspicion of AL amyloidosis.
  • For patients diagnosed with MGUS or with positive monoclonal protein serum results, MASS-FIX urine testing recommended to evaluate kidney function.
  • MASS-FIX urine recommended because dipstick urine total proteins can underestimate protein levels as they are not sensitive to Ig light chains.
  • Per CAP and IMWG guidelines, 24-hour urine testing recommended for monitoring treatment response.

RSMPU | Monoclonal Protein Screen, Random, Urine

Analytic time: 4–6 days

  • MASS-FIX urine testing, with greater sensitivity than serum for free light chains, can help detect the presence of monoclonal protein in urine that may not have been detected in other serum testing for monoclonal protein or for patients with a high suspicion of AL amyloidosis.
  • For patients diagnosed with MGUS or with positive monoclonal protein serum results, MASS-FIX urine testing recommended to evaluate kidney function.
  • MASS-FIX urine recommended because dipstick urine total proteins can underestimate protein levels as they are not sensitive to Ig light chains.

Monitoring

TMOGA | Monoclonal Gammopathy, Monitoring, Serum

Analytic time: Same day/1 day 

  • Determining if IgG kappa mass changes are caused by monoclonal therapeutics or residual disease 

MALD | M-Protein Isotype, Matrix-Assisted Laser Desorption-Ionization Time-of-Flight Mass Spectrometry, Serum

Analytic time: Same day/1 day 

  • When protein electrophoresis and free light-chain testing is performed in house; M-protein isotyping by MASS-FIX only 

How an ex-NFL linebacker overcame his greatest opponent, amyloidosis

Matt Millen, an ex-pro NFL player who played on four Super Bowl-winning teams, underwent a nearly six-year medical journey in search for answers. Finally, he was diagnosed with amyloidosis using a new testing methodology at Mayo Clinic.

Learn more about how to order this evaluation at your institution.

Additional resources

Publications from Mayo Clinic

  • Abeykoon JP, Murray DL, Murray I, et al. Implications of detecting serum monoclonal protein by MASS-fix following stem cell transplantation in multiple myeloma. Br J Haematol. 2020 Nov. 
  • Dispenzieri A, Larson DR, Rajkumar SV, Kyle RA, Kumar SK, Kourelis T, Arendt B, Willrcih M, Dasari S, Murray D. N-glycosylation of monoclonal light chains on routine MASS-FIX testing is a risk factor for MGUS progression. Leukemia. 2020 Oct;34(10):2749-2753.
  • Kourelis T, Murray DL, Dasari S, et al. MASS-FIX may allow identification of patients at risk for light chain amyloidosis before the onset of symptoms. Am J Hematol. 2018;93(11):368-E370.   
  • Kumar S, Murray D, Dasari S, et al. Assay to rapidly screen for immunoglobulin light chain glycosylation: a potential path to earlier AL diagnosis for a subset of patients. Leukemia. 2018 Jan;33(1):254-257. 
  • Mellors P, Binder M, Ketterling R, et al. Metaphase cytogenetics and plasma cell proliferation index for risk stratification in newly diagnosed multiple myeloma. Blood Adv. 2020 May;4(10):2236-2244. 
  • Milani P, Murray DL, Barnidge DR, et al. The utility of MASS-FIX to detect and monitor monoclonal proteins in the clinic. Am J Hematol. 2017;92:772-779.  
  • Mills JR, Barnidge DR, Dispenzieri A, and Murray DL. High sensitivity blood-based M-protein detection in sCR patients with multiple myeloma. Blood Cancer J. 2017;7(590).
  • Mills JR, Kohlhagen MC, Dasari S, et al. Comprehensive assessment of  M-proteins using nanobody enrichment coupled to MALDI-TOF mass spectrometry. Clin Chem. 2016 Oct;62(10):1334-1344. 
  • Mills JR,  Kohlhagen MC, Willrich MAV, et al. A universal solution for eliminating false positives in myeloma due to therapeutic monoclonal antibody interference. Blood. 2018 Aug;132(6):670-672. 
  • Murray, D.L., Puig, N., Kristinsson, S. et al. Mass spectrometry for the evaluation of monoclonal proteins in multiple myeloma and related disorders: an International Myeloma Working Group Mass Spectrometry Committee Report. Blood Cancer J. 2021:11 (24).